Thalomid Dispensing Authorization Guidelines

Dispensing prescriptions for Thalomid involves an authorization process from its manufacturer, the Celgene Corporation.

This process is standardized throughout the United States.

The medication has significant benefits, yet it also has serious potential side effects.

Once a pharmacy technician receives a prescription for the medication, he or she must call the Celgene Corporation and go through an authorization process.

Once the technician has received authorization, there is only a short window of time allowed to dispense the medication.

Authorization can be obtained either by speaking with a representative or through Celgene's automated telephone authorization process.

Thalomid (Thalidomide)

Thalomid, also known as Thalidomide, is an anti-inflammatory medication used for the treatment of skin inflammation in patients who have moderate to severe erythema nodosum leprosum.

This medicine is also classified as an “immunomodulatory agent” and an “antiangiogenic agent”.

Thalomid was developed by the German drug company Grunenthal. First it was tested on rodents and seemed to be safe.

After this, Thalomid was launched and it was used to treat anxiety, insomnia, and morning sickness in pregnant women up until the 1960s.

Between 1957 and 1961, Thalomid was sold in 50 countries under at least 40 names:

  • Talimol,
  • Distaval,
  • Nibrol,
  • Contergan,
  • Neurosedyn,
  • Sedimide,
  • Quietoplex,
  • and Softenon.

Unfortunately, this medicine was withdrawn from the market in 1961, after being linked to fetal deaths and serious birth defects.

What seemed to be a blessing for the pregnant women suddenly turned into a nightmare.

It is believed that this medicine caused nearly 10,000 birth defect cases and almost 100,000 fetal deaths between 1957 and 1961.

In 1998, Thalomid was approved again by the FDA (The US Food and Drug Administration), in order to treat ENL (erythema nodosum leprosum), a complication of leprosy.

Today, Thalomid is also prescribed to treat blood cancers. It is used in combination with Dexamethasone to treat multiple myeloma (cancer of the white blood cells.)

Thalidomide may cause nerve damage that may be severe and permanent.

This medicine can only be prescribed and dispensed by pharmacists registered with the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program.

It is not clear how Thalomid works upon cancer cells.

However, Thalomid may work by interfering with the growth of blood vessels in tumors or by decreasing cytokine and growth factor production.

This way the tumor cannot increase anymore and it stops growing larger.

Before taking Thalomid there are strict rules people must follow.

They must enter the program called “System for Thalidomide Education and Prescribing Safety” (S.T.E.P.S.) and fill out a questionnaire before and while receiving the medication.

Usually people are limited to a 28 days supply of Thalomid every time their prescription is refilled.

In order to receive more refills they have to participate in the S.T.E.P.S. program and commit to all necessary agreements.

Major precautions must be taken for people who are prescribed Thalomid. The amount of Thalidomide people can receive must be prescribed strictly by their doctor.

Only the doctor will determine the daily dosage and schedule for each patient. Thalomid is usually taken about an hour before the sleep time.

Thalomid is given orally, as a capsule (50 mg each) and should be taken with a full glass of water. This medicine should never be taken by children younger than 12 years old.

Also people should never share their Thalomid pills with others!

Never use Thalomid if you are pregnant! This is a golden rule for Thalomid. Women must have a pregnancy test within 24 hours before beginning treatment.

The biggest risk when taking Thalomid is in the first months of pregnancy, when a woman may not know she is pregnant.

So it is important that women should never take Thalomid if they plan to become pregnant. Before starting a Thalomid treatment, the patient must tell the doctor about any other medications they are already taking.

It is not allowed to take aspirin or other products containing aspirin unless the doctor permits this.

Also it is very important to avoid alcohol while taking Thalomid.

Men and women who are sexually active and take Thalomid should use contraceptives, latex condoms and spermicides to avoid pregnancy.

Otherwise, severe birth defects may results even from one single 50 mg dose. Thalidomide does not interact with the contraceptive hormones.

After a Thalomid therapy only the doctor can tell if someone is ready to conceive a child.

Women should never breast feed while taking Thalomid. Also, people should never donate blood or sperm while taking Thalomid.

Thalomid is also responsible for several side effects. The most important and the most dangerous side effect is the ability to cause birth defects.

Because of this, special care must be taken while using this medicine. Most people do not experience all side effects listed below. These side effects will go away after the treatment is complete.

The most common side effects for Thalomid are:

  • severe human birth defects;
  • sedative effects like sleepiness, weakness or mood changes;
  • skin rashes (itching, redness);
  • peripheral neuropathy (pain in the feet or hands);
  • constipation;
  • stomach pain;
  • stomach pain;
  • increase in HIV viral load (must be used with caution by patients who have HIV.)

Other side effects for Thalomid are:

  • low count of white blood cell (leucopenia);
  • dizziness, slow heart rate and weakness;
  • mood changes;
  • swelling of the ankles or feet;
  • increased appetite;
  • dry eyes;
  • leg cramps;
  • photosensitivity (sensitivity to light.)

It is important to avoid activities where sleepiness may be a problem.

Thalomid can cause a lot of sleepiness so it is very important to avoid driving the car or operating machinery while taking this medicine.

Thalomid can also cause the decrease of white blood cells. That is why blood tests must be done regularly while taking Thalomid.

People should always inform their doctor if they encounter any unusual symptoms while using Thalomid.

Only the doctor will decide if the treatment can continue or it must be stopped immediately.

Patients can also report the side effects of Thalomid to FDA at 1-800-FDA-1088.

If someone misses a dose of Thalomid, then s/he must take the dose as soon as he or she remembers.

If it is already time for the next dose, the patient should skip the missed dose and return to his/her regular dosing schedule. People should never take a double dose of this medication.

Thalomid capsules must be stored in a cool and dry place, only in their original packaging where light doesn’t reach them. People must throw away any medication that is outdated and keep the medicine away from children.

In cases of overdose, people should seek emergency medical attention or call the US Poison Help line at 1-800-222-1222.

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